Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery - Full Text View

Purpose

Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting patient outcome following cardiovascular surgeries. Propofol, an intravenously administered anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to investigate the ability of propofol to protect kidneys against I/R injury in the patients undergoing valvular heart surgery.

Condition	Intervention	Phase
Heart Valve Disease	Drug: Propofol	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery: A Prospective, Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Heart Valve Diseases

Drug Information available for: Propofol

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

Serum creatinine [ Time Frame: incidence of AKI during 48 hours after the surgery incidence of AKI ] [ Designated as safety issue: No ]
Comparison of serum creatinine elevation after surgery between Propofol and Control group.

Enrollment:	112
Study Start Date:	May 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Propofol group	Drug: Propofol Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0 µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).
Placebo Comparator: Control group	Drug: Propofol Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0 µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).

Arms

Assigned Interventions

Experimental: Propofol group

Drug: Propofol

Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0 µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).

Placebo Comparator: Control group

Drug: Propofol

Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0 µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing valvular heart surgery.
Age: 20~75.

Exclusion Criteria:

Emergency operation.
Patients with vitamin E or vitamin C within 5 days before surgery.
Patients with preoperative C-reactive protein (CRP) > 16 mg/L.
Patients with serum creatinine ≥ 2.0 mg/dL
Patients under hemodialysis.
Patients with acute myocardial infarction within 1 week before surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384643

Locations

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yonsei University

More Information

No publications provided

Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01384643 History of Changes
Other Study ID Numbers:	1-2011-0007
Study First Received:	June 27, 2011
Last Updated:	April 10, 2013
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 22, 2013